The following data is part of a premarket notification filed by Kronner Prototypes, Inc. with the FDA for Kronner Low Profile Scope Holder.
Device ID | K000663 |
510k Number | K000663 |
Device Name: | KRONNER LOW PROFILE SCOPE HOLDER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97470 |
Contact | Richard Kronner |
Correspondent | Richard Kronner KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97470 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-28 |
Decision Date | 2000-05-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856589007011 | K000663 | 000 |